Recruiting

Ketogenic Diet

Sponsor:

UCLA

Code:

NCT06540703

Conditions

Anorexia Nervosa

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Therapeutic Ketogenic Diet (TKD)

Study Details

Brief summary:

This is a longitudinal study with an open design in weight recovered anorexia nervosa (wrAN) individuals. Healthy controls (HC) will also be assessed. Study participants will be carefully assessed and will have 18F-fluorodeoxyglucose (\[18F\]FDG) positron emission tomography (PET) scans for assessment of regional brain glucose uptake. The wrAN group will be compared to healthy controls. Participants in the wrAN group will then complete 14 weeks of therapeutic ketogenic diet (TKD). At the end of the TKD study, participants will have assessments and a second \[18F\]FDG and TMS/EEG scan. Study participants will be followed over six months after the intervention. This follow-up procedure will help determine whether symptom improvement will be stable or worsen in individuals who choose to continue or discontinue the TKD intervention. This will be a naturalistic follow-up.

Conditions

Anorexia Nervosa

Study ID

NCT06540703

Start date

Oct 2, 2024

Status verified date

Apr, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

Weight Recovered Anorexia Nervosa (wrAN)

  • Age 18-45 years old
  • Male and Female sexes
  • All ethnic backgrounds
  • History of restricting-type anorexia nervosa (AN) according to DSM-5 criteria
  • Weight recovered with a body mass index > 17.5 for at least one month at the time of study
  • Elevated eating disorder-relevant behaviors on the Eating Disorders Inventory-3 and the Eating Disorder Examination Questionnaire

Healthy Control Group

  • Age 18-45 years old
  • Male and Female sexes
  • All ethnic backgrounds
  • Normal lifetime BMI according to CDC

Exclusion Criteria:

Weight Recovered Anorexia Nervosa (AN)

  • Current pregnancy or nursing (will have to agree to contraceptive measures if sexually active)
  • Lifetime history of bipolar I disorder or psychosis
  • Current substance abuse or dependence in the past 3 months
  • Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders
  • History of significant head trauma
  • Indication of intellectual disability or autism spectrum disorder

Healthy Control Group

  • No lifetime psychiatric illness and in particular no eating disorder history
  • Not be taking medication, and will not have a first degree relative with an eating disorder.

No subject in either group will have or be

  • mental retardation or pervasive developmental disorder
  • organic brain syndrome
  • dementia
  • psychotic disorder
  • bipolar disorder
  • somatic symptom
  • conversion disorder
  • current alcohol or substance use disorder
  • indication of major medical illness including a history of seizure disorder
  • pregnant or nursing at the time of the study
  • a history of traumatic brain injury.
  • diabetes mellitus or other metabolic disorders that could worsen on a ketogenic diet
  • intracranial or any other metal object within or near the head that cannot be safely removed, excluding the mouth
  • implanted neurostimulators, intracardiac lines, or heart disease

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Therapeutic Ketogenic Diet

Subjects will be placed on a therapeutic ketogenic diet (TKD) for a duration of 14 weeks.

Interventions

Therapeutic Ketogenic Diet (TKD)

2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet

Primary outcome measure

  • [18F]fluorodeoxyglucose (FDG) uptake [ Time Frame: Difference in pre/post Therapeutic Ketogenic Diet PET/CT scans ]

Central Contacts and Locations

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92121

Contacts

Megan E Shott, BS

858-246-5272mshott@health.ucsd.edu

Guido Frank, MD

gfrank@health.ucsd.edu

Principal Investigator:

Guido Frank, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-04-23.